Abstract
Coronavirus disease 2019 (COVID-19) has significantly affected human life, and preventing the spread of severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has become an important issue. Nowadays, rapid screening tests are primarily used to identify potentially infected patients and prevent viral transmission. At present, commercially available antibody-based rapid screening tests require the collection of respiratory tract samples. Sample collection is performed using methods that create discomfort. Therefore, we developed a lysis-free rapid screening test platform that can be fitted onto a medical mask. The mask can be worn for one day, after which the virus accumulates in the sampling pad. Finally, the wearer can directly activate the rapid screening test for self-monitoring by using their saliva. In this study, the structure of the novel lysis-free rapid screening test was similar to that of a commercial one. However, a lysis solution is added to the sample pad in advance and a hydrogel is added as a buffering material for viral detection. Our design improved the efficiency of combining the sample and aptamer as well as the detection efficiency. The H1N1 hemagglutinin and SARS-CoV-2 nucleocapsid protein were detected using the test platform which had a detection limit of 0.1 ng/ml. In addition, our design was validated via actual usage by patients with COVID-19 who had been ill for more than 7 d as well as healthcare workers who were close contacts and at high-risk of infection. The novel test platform can collect and accumulate viruses from patients with low viral load to achieve early viral detection and prevention of spread.
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